Securing your end-to-end supply chain
Supply chain safety, quality and reliability are key to all our Quats and Insulin Human customers. Here is how we can help you secure your supply chain, from sourcing raw materials to delivering your products as promised – even in a global crisis.
A secure supply from a pharma organisation
As part of a large pharma group, we are uniquely positioned to help both our Quats and Insulin Human customers secure their supply chains. We source our Recombinant Insulin directly from our parent company Novo Nordisk, the world’s largest producer, for a secure supply of high quality insulin. Being part of a large organisation also puts us in a strong position for sourcing raw materials from our key Quats suppliers.
We are a specialist and dedicated manufacturer of Quats in an unequalled, full cGMP grade. This reduces your supply chain risk for products such as Benzalkonium Chloride, compared with non-pharma manufacturers of multiple products or APIs. You can be sure of where our products come from and that they meet all the necessary specifications.
Quality and consistency you can rely on
Insulin production is complex: any variation in the manufacturing process, both upstream and downstream, can have serious effects on the insulin’s consistency. For the same performance every time, consistency is a must. With very few manufacturing batches a year, the large scale of our manufacturing and our highly standardised processes ensure product consistency. With a long history of compliance, our Insulin Human is manufactured in cGMP facilities, following our ISO 9001 quality system. It is analysed according to the current European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP).
All our Quats products are manufactured according to cGMP and ICH Q7 guidelines. This ensures the right quality products, with a high degree of consistency. Our multi-compendial range of products follows the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some Quats products also follow the Japanese Pharmacopoeia (JP) or the British Pharmacopoeia (BP). You therefore have complete assurance that products will meet regulatory guidelines. All our Quats activities are gathered in one site in Denmark, making supply chain audits even easier.
We provide a simple, ‘one-stop’ solution to regulatory compliance for both our Quats and Insulin Human customers, with up-front access to a full package of certificates from authorities, qualification dossiers, stability and analysis documents, and more. We also have a dedicated customer support department to provide a swift response to any questions you might have.
Delivering as promised around the world
Our Quats products are sold globally in more than 70 countries across Europe, Asia, North America, South America and Africa. We supply some of our customers directly, but we are also supported by a network of global distributors across North America, Europe, Asia, Australasia and India. This gives customers access to a local supplier and point of contact for their products. In-stock pharmaceutical products can be shipped within a week, and our entire range of products is offered in a variety of packing solutions, meeting demands for small- and large-size packaging. Our Quats products are also distributed in line with GDP and Known Consignor.
Insulin Human is filled in our own classified room facilities using tamper-proof packaging. These are placed in approved thermo-containers together with dry ice to ensure that the product is kept below the recommended maximum temperature during shipment. Customers might be surprised to learn that we do not have a requalification process; if the product is not delivered, or re-icing is not performed, the product is simply scrapped. Local distribution centres – in Indiana, USA, and near Copenhagen, Denmark – also provide short lead-times and precision delivery worldwide.
Ensuring business continuity during crisis
Covid-19 has put supply chains to the test, with gaps rapidly emerging. However, it has been more or less business as usual for us. As a pharma company, our business was deemed essential by governments around the world. By working closely with our customers, we are delivering our products as promised and without disrupting planned manufacturing processes.
We are continuing to monitor the situation closely, and of course we have business continuity plans in place to ensure ongoing, safe operations, as well as product stockpiles to cover customer requirements.
For more information, please contact:
Insulin: Timur Özbay at [email protected]
Quats: Phil Stafford at [email protected]
You can download the article here.